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Posts Tagged ‘Arterial blood gas’


Reporter; Aviva Lev-Ari, PhD, RN

October 1, 2012 by MassDevice staff

More turnover at Stryker as the orthopedics giant names Kevin Lobo, former head of the orthopedics division, its new president & CEO.

Updated October 1, 2012 at 1:20 p.m. with comments from Stryker.

Stryker CEO Kevin Lobo

There was more turnover at orthopedics giant Stryker (NYSE:SYK) as the company pulled from its own ranks to name Kevin Lobo its new president & CEO.

Lobo replaces interim CEO Curt Hartman, who is leaving the company after a transitional period, the Wall Street Journalreported. Hartman was also CFO for the company, a role he held since April 2009.

“After a very thorough search process involving external and internal candidates, we are pleased to name Kevin Lobo as Stryker’s president and chief executive officer,” Stryker non-executive board chairman William Parfet said in prepared remarks. “Since joining Stryker in 2011 he has proven to be a highly effective leader for our Orthopedics Group, and he has won the confidence of employees, customers and the Board.”

Source:

http://www.massdevice.com/news/stryker-appoints-names-lobo-ceo-cfo-hartman-prepares-leave

 

 

“Mr. Lobo joined Stryker in April 2011 and most recently served as group president, orthopedics,” according to Lobo’s executive bio. “Prior to joining Stryker, Mr. Lobo served in several senior leadership roles at Johnson & Johnson (NYSE:JNJ), including as worldwide president of Ethicon Endo-Surgery.”

Not Having 510(k) Clearance, FDA Recall advised and Patient to Return Certificate of Medical Necessity form to Stryker by Oct. 2012: Neptune Rover Waste Management System in the United States, Asia Pacific, Canada, Japan, Latin America and EMEA. Following recall of  Hip Implant Recall by Stryker Orthopaedics Rejuvenate Modular Hip Systems in July 2012.

Urgent Medical Device Recall – Stryker Issues Class 1 Recall of Neptune Rover Waste Management System in the United States, Asia Pacific, Canada, Japan, Latin America and EMEA
KALAMAZOO, Mich., Sept. 25, 2012  /PRNewswire/ — On June 5, 2012, Stryker initiated a Class 1 recall of the Neptune Waste Management System. The devices are being recalled because Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube post operatively, resulting in a fatality.

The recall includes all serial numbers for the following model numbers:

Product Name Catalog Number Manufacture Dates Distribution Dates IFU Part Number
Neptune 1 Gold Rover 0700-001-000 1/11/01 – 12/23/09 3/26/01 – 1/30/10 0700-001-700
Neptune 1 Gold Rover – International 0700-002-000 9/15/05 10/3/05 – 10/3/05 0700-002-707
Neptune 1 Silver Rover 0700-003-000 1/31/02 – 9/3/09 5/31/02 – 11/19/09 0700-001-700
Neptune Bronze 0700-007-000 3/22/04 – 2/22/12 3/31/04 – 6/27/12 0700-007-720
Neptune 2 Rover Ultra (120 V) 0702-001-000 12/3/07 – 8/1/12 12/31/07 – 8/7/12 0702-002-700
Neptune 2 Rover Ultra (230 V) 0702-002-000 10/9/08 – 6/18/12 3/5/09 – 7/26/12 0702-002-700

On June 5, 2012, Stryker notified customers that it was recalling the IFUs for the above products. The current IFU did not specifically warn against connecting the Neptune Rover, which is a high vacuum/high flow device, to a passive drainage tube. Customers were instructed to review the revised IFU, distribute to affected departments, and educate users of the Neptune on this warning.  Customers must confirm with Stryker via business reply form that they have completed these actions.

Customers who have the Neptune 1 Gold, Neptune 1 Gold International or Neptune 1 Bronze will receive a follow up mailing in October containing warning labels for the device and instructions detailing how to apply them.  Customers may continue to use the Neptune 1 Gold, Neptune 1 Gold International, and the Neptune 1 Bronze.  Users must be aware of the warning that was added to each device.

On September 18, 2012, Stryker notified customers via letter delivered by FedEx overnight delivery that it is expanding the recall on the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V)  because FDA has also advised Stryker that these devices require, but do not currently have, 510(k) clearance. FDA is therefore unable to determine whether these devices are as safe and effective as their legally marketed predicate, the Neptune 1 (Gold) Waste Management System (510(k) K012992).  As such, Stryker has ceased distribution of the Neptune Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) devices until FDA clears these devices.

At this time, FDA does not consider the Neptune Silver, the Neptune 2 Ultra (120V) or the Neptune 2 Ultra (230V) to be legally marketed devices because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used.  However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices. If customers choose to continue use of the Neptune Silver, Neptune 2 Ultra (120V) or Neptune 2 (230V), they must complete a Certificate of Medical Necessity and return it to Stryker by October 12, 2012.

Customers who submit their signed Certificate of Medical Necessity to Stryker will receive a follow up mailing containing warning labels for the device and instructions detailing how to apply them.

Customers who have questions about this recall should contact Stryker Instruments’ Recall Coordinator, Angela Ragainis, Monday – Friday, 8am – 5pm ET, at 269-389-2316 or strykerinstrumentsrecalls@stryker.com.

Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to Stryker by calling 1-800-253-3210 or by using the FDA’s MedWatch Adverse Event Reporting program either online athttp://www.fda.gov/Safety/MedWatch/HowToReport or by phone at 1-800-332-1088.

About Stryker

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. For more information about Stryker, please visit www.stryker.com.

SOURCE Stryker

http://www.stryker.com

http://www.prnewswire.com/news-releases/urgent-medical-device-recall—stryker-issues-class-1-recall-of-neptune-rover-waste-management-system-in-the-united-states-asia-pacific-canada-japan-latin-america-and-emea-171202271.html 

NEW YORK, Sept. 25, 2012 /PRNewswire/ — Seeger Weiss LLP advises that on July 6th, 2012, Stryker issued a voluntary recall of its Rejuvenate Modular Hip System and ABG II Modular-Neck stems due to mounting evidence that its design has led to major complications in hundreds of patients. According to the Stryker press release, these implants have an increased risk of “fretting and corrosion at the modular-neck junction.”The development is the latest in a string of recalls related to hip replacement devices that utilize metal-on-metal components, which have been linked to instances of metallosis, muscle damage and complete hip implant failure.

Hip replacement surgery, otherwise known as arthroplasty, is currently one of the most commonly practiced orthopedic surgeries  in the United States, with the Agency for Healthcare Research and Quality estimating that more than 285,000 hip replacements are performed each year within the country. In an article published on December 27th, 2011, the New York Times categorized the hip replacement crisis as “the most widespread medical implant failure in decades.”

There has been a sharp rise in the number of problems associated with the use of prostheses featuring either all-metal designs or designs that contain parts that produce metal-on-metal friction. While the Stryker Rejuvenate is not a metal-on-metal hip device, it has a metal neck piece that can, under some conditions, rub against a metal stem, causing metallic debris to come loose, and in some instances, cause metallosis.

Metallosis is an adverse tissue reaction to heavy metals in the body. It can cause pain, limited mobility, failure of the hip joint, pseudo-tumors, dissolution of the bone, DNA changes and chromosomal aberrations.

The result is that injured hip replacement patients are starting to file claims against Stryker. “The abundance of evidence against the integrity of the metal-on-metal design raises serious questions as to whether Stryker practiced due diligence before releasing their product to the market,” says Chris Seeger, partner at Seeger Weiss LLP. “If it is established that Stryker put company profits ahead of patient safety, then legal action may be necessary to provide justice for those injured.”

As industry leaders with decades of experience successfully representing plaintiffs in these types of injury cases and recovering large financial awards, the partners at Seeger Weiss LLP have the expertise to provide just compensation for individuals who have suffered injuries as the result of faulty hip implants. If you or a loved one has suffered an injury due to Stryker hip replacements, visit http://www.hipimplantrecall.com/ or call 888.584.0411 for a free case evaluation.

Contact: Patricia Issacson, 212-584-0700, PIsaacson@seegerweiss.com

http://www.prnewswire.com/news-releases/hip-implant-recall-stryker-orthopaedics-recalls-rejuvenate-modular-hip-systems-171200681.html

Stryker Recalls Neptune Devices After Death Reported

By Michelle Fay Cortez – Sep 25, 2012 4:18 PM ET

Stryker Corp. (SYK) stopped selling three versions of its Neptune Waste Management System after two people were harmed, one fatally, using the devices that were sold without formal clearance by U.S. regulators.

Stryker initiated a Class 1 recall, the most serious device withdrawal, on June 5 after two reports of serious injury from the products used to collect fluid waste during surgery, the Kalamazoo, Michigan-based company said today in a statement. In one instance, a patient’s passive chest drainage tube was hooked to the Neptune 2 System, a high-vacuum, high-flow device. The patient died, Stryker said.

The initial recall was intended to inform customers that the devices shouldn’t be connected to passive drainage tubes, a warning that wasn’t on the label. The company extended the recall on Sept. 18 to inform customers that the Neptune 1 Silver, Neptune 2 Ultra and a higher-powered Neptune 2 Ultra don’t have U.S. Food and Drug Administration approval.

The FDA doesn’t consider the devices “to be legally marketed devices because their safety and effectiveness have not yet been determined,” the company said in the statement. “As such, FDA advises that the devices not be used.”

Stryker stopped distributing the devices. Customers who don’t have an alternative machine available should weigh the risks and benefits of the recalled Neptune devices and request a certificate of medical necessity if they plan to continue using them, the company said.

Stryker fell less than 1 percent to $55.98 at the close in New York. The shares have risen 21 percent in the past 12 months.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis atmcortez@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

http://www.bloomberg.com/news/2012-09-25/stryker-recalls-neptune-devices-after-death-reported.html

Tue Sep 25, 2012 3:35pm EDT

(Reuters) – Stryker Corp said on Tuesday it expanded the recall of its Neptune surgical waste management product line to include later versions because U.S. health authorities have advised the company that these devices do not have proper regulatory clearance.

In June, the company issued a Class 1 recall, the most serious type, of its Neptune waste system after receiving two reports of serious injury and a fatality resulting from the use of the product.

The device collects surgical waste in the operating room and then disposes of the fluids without ever exposing healthcare workers to the waste.

Stryker also notified customers that it was recalling the instructions for use because they did not specifically warn against connecting the high vacuum/high flow device to a passive drainage tube.

In a press release, Stryker, a maker of hospital beds and orthopedic implants, said the U.S. Food and Drug Administration is unable to determine whether these last-generation devices are as safe and effective as their legally marketed predecessor, the Neptune 1.

The recall affects the following products: Neptune 1 Gold Rover; Neptune 1 Gold Rover – International; Neptune 1 Silver Rover; Neptune Bronze; Neptune 2 Rover Ultra (120 V); and Neptune 2 Rover Ultra (230 V).

(Reporting by Debra Sherman; Editing by Gerald E. McCormickand Leslie Adler)

http://www.reuters.com/article/2012/09/25/us-stryker-recall-idUSBRE88O16U20120925

Stryker recalls models of waste management product that did not have requisite 510(k)s

September 25, 2012 3:55 pm by  | 0 Comments

medical device recall 510(k) process PMA

Stryker issued an urgent medical device recall notice Tuesday noting that it was expanding the recall to newer models of a waste management product recalled previously because it was selling those products without the necessary regulatory clearance.

The recall of the Neptune Rover Waste Management System appears to be a worldwide recall. The devices are being recalled because”Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube postoperatively,” killing the patient.

The company said that the U.S. Food and Drug Administration informed Stryker that the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) Waste Management systems do not have the requisite 510(k) clearance and customers should stop using these devices. The previous recall was designated a Class I.

As a result of the expanded recall, Stryker is no longer selling these products. Neptune 1 (Gold) Waste Management System is the predicate device for the models being recalled. Those customers who are using the Neptune 1 Gold,Neptune 1 Gold International and the Neptune 1 Bronze will receive follow-up letters containing the warning labels that now need to be applied with these devices.But the announcement noted customers who are currently using the recalled models and do not have an alternative can continue to use them although they need to complete and return a Certificate of Medical Necessity form to Stryker by Oct. 12.

It wasn’t clear from the announcement why these later models of the Neptune 1 Waste Management System were being sold without a 510(k) clearance. A Stryker spokeswoman declined to comment.

http://medcitynews.com/2012/09/stryker-recalls-models-of-waste-management-product-that-did-not-have-requisite-510ks/

Stryker recalls pair of metal hip implants, halts global production

July 6, 2012 by MassDevice staff

Orthopedic devices maker Stryker recalls a pair of metal-on-metal hip implants and halts global production after discovering potential for “fretting and/or corrosion” that could cause pain, swelling and tissue damage.

hip ipmlant x-ray

Orthopedic devices giant Stryker (NYSE:SYK) announced recall of a pair of hip implants over concerns that the devices may be prone to “fretting and/or corrosion at or about the modular-neck junction,” which may lead to pain, swelling and adverse reactions in surrounding tissue.

http://www.massdevice.com/news/flash-stryker-recalls-pair-metal-hip-implants-halts-global-production

Massachusetts Stryker Recall Warning:Rejuvenate & ABG II Modular Hip Systems

If you live in Massachusetts and were implanted with a Stryker Rejuvenate hip replacement or a Stryker ABG II hip replacement, you may be at risk for a corrective hip revision surgery. Stryker Orthopaedics warns that fretting and corrosion (wear and tear) can occur within these medical devices. Patients may experience the dangerous side effects of Metallosis (metal poisoning). Hospitalization and painful corrective surgeries are sometimes necessary if a blood test indicates elevated metal levels (cobalt and/or chromium) in a patient’s blood.

Our Stryker hip attorneys are most concerned with the following complications:

  • Implant wear and tear (corrosion or fretting)
  • Metallosis or Metal Poisoning (metal debris causes elevated metal ions in the patients blood)
  • Broken or fractured implants
  • Pseudo-tumors
  • Allergic responses or hypersensitivity
  • Unexplained pain or swelling in leg, hip or groin

Which Stryker Hip Replacements Have Been Recalled?

  • Rejuvenate Modular Hip System recall
  • ABG II modular-neck hip stem recall

Massachusetts patients can verify the model of their hip implant by requesting the operative report from the medical records department at the hospital where the implant surgery took place; or by discussing personally with your surgeon. If you have difficulty finding our whether your implant was part of the Stryker recall, contact us, our Stryker hip lawyers can assist you.


Serious Health Risks Associated with Stryker Hip Recall

Metallosis occurs when metallic debris builds up in the soft tissue around the artificial hip. In the case of the recalled Stryker hip devices, recalled devices are capable of deteriorating and creating metal debris over time. Corrosion or fretting of the device releases microscopic metallic ions of cobalt and chromium into the body, causing an autoimmune response. Metallosis can be further complicated by metal sensitivity or an allergic reaction to metal.


Know Your Legal Rights. Our Law Firm Can Help!

Our Stryker Rejuvenate lawyers are highly experienced in medical device litigation, and we have an impressive record of success to prove it. If you or a loved one has been implanted with a Rejuvenate or ABG II modular hip system in Massachusetts, contact us right away so we can answer your questions, evaluate your claim and explain your legal rights.


Stryker Orthopaedics Recalls Rejuvenate Modular Hip System

In July 2012, Stryker Orthopaedics voluntarily recalled its Rejuvenate Modular Hip System. The recall includes both Stryker’s Rejuvenate Modular and ABG II modular-neck hip stems.

Risks

Stryker initiated this voluntary recall due to potential risk associated with modular-neck stems. This risk includes:

  • possible fretting and/or corrosion at the modular-neck junction, which may result in pain and/or swelling.

Other risks associated with Stryker’s hip replacements include:

  • Joint loosening/dislocation
  • Device wear and tear, such as corrosion and fretting
  • Excessive metal debris leading to metal ion generation
  • Inflammation of tissue
  • Hypersensitivity/allergic response
  • Broken devices

Early Failure Rates

The Stryker Orthopaedics Rejuvenate Modular Hip System is associated with early failure rates. Most hip replacements last up to 20 years; however, Stryker Orthopaedics’ device may begin to malfunction at only six months. If you are experiencing any problems with your Stryker Orthopaedics hip implant, including any swelling or other seemingly mild discomfort, you may be eligible for compensation, and you need to contact an experienced attorney right away.

History of Problems with Stryker’s Hip Implants


Stryker Orthopaedic’s voluntary recall follows a May 2012 Health Canada recall and an April 2012 Urgent Safety Alert that Stryker released about serious health risks associated with the product.

The FDA issued warnings to the company from 2005 – 2007 before instituting, in January 2008, a nationwide recall of parts manufactured for use in the socket portion of hip replacements. The FDA recalled the products citing reports that the methods used in Stryker’s manufacturing plants did not conform with good manufacturing practices and that ‘manufacturing residuals’ at levels that exceeded company standards could contaminate the components.

 If you Have Pain…


Stryker Orthopaedics advises recipients of the Rejuvenate Modular Hip or ABG II modular-neck hip stem who have pain or swelling around the replaced hip, to contact their surgeons. Recipients who have no pain, should continue following the post-operative plan outlined by their doctors, the company says.

http://strykerhiplawsuits.com/recall-news/

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